May 24 (Bloomberg) -- Wockhardt Ltd., an Indian maker of
insulin and hepatitis vaccines, will not win new drug approvals
this year for about half the pending applications in the U.S.
after that nation’s regulator placed import curbs on a plant.

The Food and Drug Administration’s restrictions apply to
Wockhardt’s Waluj facility in Aurangabad, which accounted for
half of the 40 new drug applications, Chairman Habil Khorakiwala
told analysts in a conference call today. The U.S. regulator
issued an import alert for products from the plant because the
section that makes injectable drugs didn’t meet its standards,
he said.

Wockhardt is the latest in a string of injectables-makers
including India’s Aurobindo Pharma Ltd. and Lake Forest,
Illinois-based Hospira Inc. that have come under scrutiny as the
FDA steps up surveillance of quality control for injectables
manufacturing. As more drugs lose patent protection, the global
market for generic injectable medicines will swell 42 percent to
$17 billion by 2020, according to Citigroup Inc.

“The problem is not just getting the old products back,”
said Anand Bagaria, an analyst at Finquest Securities Pvt. in
Mumbai who plans to review his rating of Wockhardt. “Whatever
major approvals they’ve filed from the factory are not going to
go through until the import restrictions are cleared. Growth
will be impacted from that.”

Wockhardt had its biggest ever two-day plunge in Mumbai
trading. The shares fell 6.1 percent to close at 1,234 rupees,
extending their two-day decline to 25 percent. The stock jumped
more than fivefold last year.

$100 Million Sales

Wockhardt will lose about $100 million in revenue as a
result of the import alert in the year ending March 2014,
Khorakiwala said. It will take the Mumbai-based company at least
eight months to get the restricted products back on the U.S.
market after it applies for new approvals and moves 80 percent
of its production from Waluj to two other Indian facilities, he
said.

“We will not receive new approvals from this facility
during the year,” Khorakiwala said. Regaining market share in
existing products which have come under the import alert could
also be a challenge, he said.

The drugmaker is due to report annual earnings on May 27.
Revenue is projected to have climbed 21 percent to 56.1 billion
rupees ($1 billion) in the 12 months ended March, according to
the median of 11 analysts’ estimates compiled by Bloomberg.

Wockhardt in an April 15 statement on its website said the
FDA had carried out an inspection at its unit manufacturing
injectables for export in Aurangabad. The agency had issued form
483s, a note given to company management when inspectors see
conditions that may violate the U.S. Food Drug and Cosmetic Act.

“If we lose market share in the worst case scenario, to
gain back market may also be challenging,” Khorakiwala said.
“We may lose out because of that dynamic also.”